FDA Trans-Fat Order Sets the Table for More Food Product “Regulation by Litigation”

To no one’s surprise, the Food and Drug Administration (FDA) has confirmed its November 8, 2013 initial determination that the agency no longer considers the main source of trans fat in Americans’ diet, partially hydrogenated oils (PHOs), “generally recognized as safe” (GRAS). In its announcement, FDA emphasizes how the three-year window it has granted food companies to comply with the order would “allow for an orderly [transition] process.” Before anyone applauds FDA for being reasonable or magnanimous, however, consider what else the agency says, and doesn’t say, in its Declaratory Order (“Order”). FDA’s statements and omissions essentially set the table for an explosion of private lawsuits that could requirePHO-containing products to be reformulated, or removed from the market, far earlier than June 2018.

What the Order Says. Under federal law, an FDA determination that a substance is no longer GRAS is not the equivalent of it being “unsafe.” It means that because some level of uncertainty has arisen from studies of the substance, food producers must seek approval for its use in specific products through a food additive petition. The Order, however, glosses over this inconvenient nuance, and instead consistently and repeatedly states that FDA has concluded PHOs are unsafe. The media has slavishly echoed FDA’s distorted conclusion to an American public that includes prospective judges and jurors for the lawsuits to come.

FDA’s Order also concludes that no measurable level exists at which PHOs won’t increase disease risk. The agency does not, therefore, back off the rather alarming statement it made in its initial PHOs determination that “any incremental increase in trans fat consumption increases the risk of CHD [coronary heart disease].” Such Naderite “unsafe at any speed” assertions are manna from heaven for plaintiffs’ lawyers. They not only exponentially expand the number of plaintiffs that lawyers can claim to represent in class actions, but they also further magnify public fear and may encourage precautionary judicial decision-making.

The agency further encourages litigation with its curious assessment of the Order’s impact on state or local laws regarding PHOs. After noting that the Food, Drug & Cosmetic Act contains no express provision that limits state or local laws or common law duties (i.e. court-made law), FDA then “decline[s] to take a position regarding the potential for implied preemptive effect.” But in the very next sentence, the agency turns on a dime and makes the bold, unsupported declaration, “FDA believes, however, that state or local laws that prohibit use of PHOs in food are not likely to be in conflict with federal law, or frustrate federal objectives.” If the Order’s objective was in part “an orderly [transition] process” away from PHOs over three years, the agency’s unsolicited opinion on federal preemption begs the question: how do successful state-law consumer protection suits, requiring immediate product withdrawal, not frustrate that objective?

What the Order Fails to Say. Two key omissions from the Order also support regulation by litigation of PHOs. First, despite being urged to do so by numerous stakeholders, FDA refuses to include an explicit statement that PHO-containing products currently on the shelves or introduced into commerce up to June 2018 are marketed lawfully. Products containing unapproved additives are considered adulterated and subject to seizure. Plaintiffs’ lawyers suing food companies will argue that the presence of PHOs renders the targeted product illegal under federal law, and thus in violation of identical state laws. Companies will argue that in setting a two-year compliance period, FDA implicitly concluded that PHO-containing foods would be compliant until June 2018. Why would FDA leave it for the courts to divine whether this was the Order’s intention? The agency also could have stated it would exercise its enforcement discretion and refrain from seizing PHO-containing food during the compliance period. But it includes no such statement.

Second, FDA says nothing about its GRAS-status decision having only prospective effect. Food industry stakeholders had sought an assurance that PHO-containing products on the market since the 1950s had been marketed lawfully. Companies are probably not concerned that FDA is going to punish them for past marketing. Rather, apprehension over ruinous retroactive private or even government-led lawsuits likely motivated companies’ request for this clarification. Private class actions could assert product liability claims, public nuisance claims, and claims for medical monitoring. City attorneys and state attorneys general may sue for reimbursement of public health care expenditures for the costs of treating cardiovascular disease, Type-II diabetes, and other conditions.

A Silent Delegation? At best, the Order’s statements and omissions reflect an FDA that is woefully naive about the larger public health crusade against “Big Food.” At worst, FDA is silently (and improperly) delegating the job of forcing rapid removal of PHOs to private lawyers and politically-ambitious state officials. For the past five years, FDA has sat on its hands as hundreds of class action lawsuits have sought to enforce federal food labeling rules on nationally-marketed products. Even if FDA is not consciously setting the table for PHO-oriented lawsuits, targeted companies should not expect the agency to step in and defend its regulatory turf.

The suits have already begun. Just two days after the Order’s release, plaintiffs’ lawyers at the Weston Firm filed their latest lawsuit, Backus v. Heinz (the firm’s 19th PHO-oriented suit by our count). The complaint cites the agency’s GRAS decision and claims that the company’s frozen potato products are now unlawfully adulterated. Commenting on FDA’s Order, name partner Gregory Weston told Politico, the action “should have taken place at least 20 years ago, and there is no justification for any sort of further delay or phasing.”

Regardless of whether FDA meant to aid attorneys like Mr. Weston or blundered into doing so, the fear, uncertainty, and needless expenditure of resources that a wave of PHO-related litigation will provoke are decidedly contrary to public health and the public interest. If FDA is unwilling to provide additional guidance and undertake other measures that can ensure orderly compliance with its Order, it may be necessary for other branches of government to step in and remind the agency of its duties under federal law.